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Senior Analyst

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Job Location drjobs

Bengaluru - India

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

JOB DESCRIPTION

Job Title: Senior Analyst

Job Location: Syngene International Limited Bengaluru

About Syngene: Syngene () is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability including following safety guidelines procedures and SOPs in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

Core Purpose of the Role:

This is an exciting opportunity to play a role in the Quality control department of Syngene. The role will provide several responsibilities of Analysis documentation Lab safety requirements Compliance as per Syngene policy and EHSS requirement. It provides an opportunity to handle overall analysis of QC and Stability samples.

Role Accountabilities

        1. Analysis of Raw Material/ In process samples/ cleaning samples/ Intermediate samples/Finished product/water sample/ Packaging materials/ Formulation finished products and management/traceability of Reserve samples and Visual inspection samples.
        2. Maintenance of sampling tools as per the standard operating procedure.
        3. Packing and Maintenance of reserve samples and visual inspection samples as applicable
        4. Carry out the analysis on the qualified techniques as per the approved specification/protocol/procedures and Interpret the data from analytical instruments and report the results and submit the completed documents for review promptly.
        5. Preparation of Certificate of analysis
        6. Recording of analytical observations/ findings reporting of data and results in observation data sheets forms logbooks LIMS and ELN application softwares.
        7. Reporting of any abnormal observation identified during analysis to reporting manager/Group leader/HOD immediately.
        8. Calibration of Instruments and perform HPLC lamp intensity test as per schedule hot water flushing of HPLC and general preventive checks for laboratory instruments.
        9. Creation/ preparation of documents master data/ static data creation in LIMS ELN and LMS Softwares as applicable.
        10. Initiation of QMS elements and other documents in Trackwise and EDMS application softwares.
        11. Record updation for Outsourcing of sample testing based on requirement and updating respective Logbooks.
        12. Coordination with engineering & maintenance and external vendor for preventive maintenance and calibration activity.
        13. Initiation of Change control CAPA deviation Laboratory Incident OOS OOT Non-Conformity as applicable.
        14. Disposal of left-over Sample after review/approval of analytical report /Release.
        15. To indent the chemicals glassware document instrument and accessories required for performing analysis as per the plan.
        16. Archive and retrieve documents related to the section.
        17. Adherence to Good Laboratory Practice and Good documentation practices.
        18. Cleaning of workplace and following Good Laboratories Practices while working in QC Laboratory.
        19. Individuals working in the GMP environment are responsible for documenting/record the activities contemporaneously and accurately as per Good documentation practices.
        20. Handling of LMS LIMS ELN TrackWise and EDMS Softwares for routine activities as applicable.
        21. Responsible for taking any other job allocated by Head QC / Group Leader /Section Head/ Section In-Charge.
        1. In addition the responsibility of the standard management team as;

Syngene Values

All employees will consistently demonstrate alignment with our core values

Specific requirements for this role

Experience: 3-6 years

Skills and Capabilities

Expertise in handling multiple Instruments/ equipment like HPLC Dissolution tester KF and GC.

Capable of thinking scientifically to address complex problems and develop solutions.

Work as a team and have a collaborative mindset.

Good communication skills.

Education: MSC/ B. Pharma

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.


Required Experience:

Senior IC

Employment Type

Full Time

About Company

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